Summary

This is a prospective, single arm phase II study to evaluate the efficacy and safety of
fulvestrant as a maintenance hormone therapy after first-line chemotherapy for
postmenopausal HR positive advanced breast cancer.

Eligible patients will receive fulvestrant 500 mg intramuscular injection on day 1, 15, and 29， then every 28 days.
The treatment will continue until disease progression or intolerable AE.

Primary Outcomes

Measure

Clinical Benefit Rate

time frame:
1 year

Secondary Outcomes

Measure

Progression Free Survival (PFS)

time frame:
1 year

Objective Response Rate(ORR)

time frame:
1 year

Number of Participants with Adverse Events

time frame:
1 year

Eligibility Criteria

Female participants of any age.

Inclusion Criteria:
Provision of informed consent Histologically proven HR positive breast cancer
Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based
on the NCCN definition of menopause [National Comprehensive Cancer Network 2008]):
Prior bilateral oophorectomy Age ≥60 years Age <60 years and amenorrheic for 12 or more
months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and
follicle stimulating hormone and oestradiol in the postmenopausal range.
Patients have completed first-line chemotherapy for metastatic breast cancer The
first-line chemotherapy must be given to patients with visceral disease or progressive
disease requiring a fast response Responded(CR or PR) or stabilized(SD>=24 weeks) to
first-line chemotherapy for metastatic breast cancer The duration of 1st line chemotherapy
for advanced breast cancer had been at least 4 cycles and at most 8 cycles WHO performance
status 0, 1 or 2-
Exclusion Criteria:
- Presence of life-threatening metastatic visceral disease, defined as extensive
hepatic involvement, or any degree of brain or leptomeningeal involvement (past or
present) Prior hormonal treatment for metastatic breast cancer are not allowed More
than one line of cytotoxic chemotherapy for metastatic breast cancer Her-2 positive
Other malignant tumor (concurrent or previous). Any severe concomitant condition
which makes it undesirable for the patient to participate in the trial or which would
jeopardise compliance with the study protocol, eg, uncontrolled cardiac disease or
uncontrolled diabetes mellitus

This is a prospective, single arm phase II study to evaluate the efficacy and safety of
fulvestrant as a maintenance hormone therapy after first-line chemotherapy for
postmenopausal HR positive advanced breast cancer.
Approximately 58 women who have stable disease or responded to first line chemotherapy with
at least 4 and less than 8 weeks of treatment for metastatic breast cancer will be enrolled
to this study and receive fulvestrant 500mg as a maintenance therapy. The treatment will
continue until the objective disease progression or intolerable AE.
Efficacy will be determined based on tumor assessments performed by each investigator
according to RECIST (Response Evaluation Criteria in Solid Tumors ) 1.1. Safety will be
monitored based on the frequency and severity of adverse events (AEs), as assessed by Common
Terminology Criteria (CTC) grade version 4.0.
Tumor assessments will be assessed by computed tomography (CT) or magnetic resonance imaging
(MRI) every 12 weeks for all patients until documented evidence of objective disease
progression.
Reporting of SAEs (serious adverse events) to regulatory authorities will be done by the
investigator in accordance with local regulations.

Trial information was received from ClinicalTrials.gov and was last updated in April 2016.